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Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
In the United States several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the Manufacturer and User Facility Device Experience Database (MAUDE) and the Special Nutritionals Adverse Event Monitoring System. MedWatch is the main reporting center, operated by the Food and Drug Administration.
2 FDA has approved Vascepa for one use, but doctors have widely, and lawfully, prescribed it for another. Amarin wishes to make truthful statements to doctors relating to Vascepa’s off -label use.
In medicine, a side effect is an effect of the use of a medicinal drug or other treatment, usually adverse but sometimes beneficial, that is unintended. Herbal and traditional medicines also have side effects.
A pharmacist, also known as a chemist in Commonwealth English, is a healthcare professional who is knowledgeable about preparation, mechanism of action, clinical usage and legislation of medications in order to dispense them safely to the public and to provide consultancy services.
Title: Exhibit 43 Author: gshapiro Keywords: None Created Date: 1/13/2010 4:14:22 PM
Bedaquiline, sold under the brand name Sirturo, is a medication used for the treatment of active tuberculosis. [1] Specifically, it is used to treat multi-drug-resistant tuberculosis along with other medications for tuberculosis.